The MySmartCare360™ assessments are designed as screening tools to detect potential cognitive decline or changes, with the aim of facilitating physician-guided therapeutic intervention. In a clinical context, MySmartCare360™ results (when interpreted by a qualified healthcare professional) may serve as a screening aid to help determine whether an individual should be referred for further neuropsychological evaluation (such as a comprehensive neuropsychological examination). MySmartCare360™ does not provide direct medical diagnoses of conditions like ADHD, dyslexia, dementia, or other similar disorders. A diagnosis can only be made by a licensed physician or psychologist, considering a wide array of factors.

In line with the intended use outlined above, MySmartCare360™ assessment tools are classified as Medical Devices by the FDA. These tools are intended for use in healthcare settings for a range of cognitive-related assessments. When used for research purposes, the product must be employed in accordance with appropriate human subjects’ procedures as established by the researcher's institution, and it is the researcher's responsibility to ensure compliance. All human subject protections will, at a minimum, adhere to the requirements set forth under Section 45 CFR 46 of the Code of Federal Regulations.